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Evaluation of Regret in Kidney Transplantation

NCT ID: NCT05282381

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-07-31

Brief Summary

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Decisional regret is a negative feeling, involving distress or remorse following a decision. This has been studied in several areas such as psychology, economy or marketing. Patients suffering from end-stage renal disease may choose between dialysis and transplantation. This decision-making process is shared with the nephrologist, who explained to the patient the pros and cons of these two possibilities. Although transplantation offers a better life expectancy and quality of life than dialysis, nothing is known about the proportion of patients regretting their choice to be transplanted. The DONOR study aims to determine the proportion of patients regretting their decision, in a prospective cohort of renal transplant recipients. The decisional regret will be assessed by the DRS ("Decisional Regret Scale"), associated with the RetransQoL, a quality of life questionnaire.

Detailed Description

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Conditions

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Renal Transplant Candidate for Right Kidney Renal Transplant Candidate for Left Kidney

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort of renal transplant recipients

DRS : Decision Regret Scale

Intervention Type BEHAVIORAL

The DRS is a self-administered questionnaire including 5 items assessing decisional regret in a score graduated between 0 and 100 (0 = no regret).This scale is associated with the ReTransQoL, a specific quality of life questionnaire.

Questionnaires are administrated at 1, 3, 6 and 12 months post-transplantation.

Interventions

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DRS : Decision Regret Scale

The DRS is a self-administered questionnaire including 5 items assessing decisional regret in a score graduated between 0 and 100 (0 = no regret).This scale is associated with the ReTransQoL, a specific quality of life questionnaire.

Questionnaires are administrated at 1, 3, 6 and 12 months post-transplantation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Kidney transplantation in the Lille University Hospital
* Functional kidney graft after 28 days post transplantation

Exclusion Criteria

* Previous other solid organ transplant
* Combined transplantation (kidney and liver for example)
* Cognitive disorders
* Lack of French language skill
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mehdi Maanaoui, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CHU Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mehdi Maanaoui, MD

Role: CONTACT

[email protected]
0320445962 ext. +33

Facility Contacts

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Mehdi MAANAOUI, MD

Role: primary

[email protected]

Other Identifiers

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2021-A02002-39

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0272

Identifier Type: -

Identifier Source: org_study_id